Abstract: A dynamic stabilization device includes end caps that define a bore for receiving a corresponding bone screw therethrough. A spacer is engaged between each end cap and a cable passes through each of the components and is placed in tension to couple the spacer between the two end caps. The spacer is formed of a material that allows some flexible movement after implantation. An alternative stabilization device includes a spacer over-molded about two bushings defining the bores. According to a method of use, a stabilization device is passed along guide wires through a small incision. Once the device is in contact with the vertebrae, the bone screws are advanced along the guide wires and driven into the bone. One fastener bore may include a camming surface that causes distraction of the vertebrae as the bone screw is threaded into the vertebral bone.

Abstract: A silicone composition having the formula: wherein R1 are independently selected from the group consisting of: an alkyl having 1-5 carbon atoms, a substituted alkyl having 1-5 carbon atoms optionally substituted by one or more fluorine atoms, and a phenyl, and R2 is selected from the group consisting of: hydrogen, alkyl of 1 to 45 carbon atoms, substituted alkyl of 1 to 45 carbon atoms optionally substituted by one or more fluorine atoms, aryl, a partially esterified ester-containing and a reverse ester thereof; provided that if R1 is anything but methyl or ethyl, then R2 must be a methyl, ethyl or butyl.

Abstract: A vented needle is provided for sealably injecting biomaterial into an intradiscal space interiorly of the annulus of a spinal disc and for providing an exhaust for the intradiscal space. The vented needle comprises a compressible seal body for pressing against an outer surface of the annulus, and a needle extending through the seal. The needle may be configured to connect to a syringe for pressure injection of the biomaterial. The seal includes a vent extending therethrough with an opening for communication with the intradiscal space and an opening for the discharge of excess biomaterial filling the intradiscal space. A kit of parts is also provided for use in the treatment of a spinal disc, the kit comprising the vented needle and an inflatable trial device. The trial device is removably introduced into the intradiscal space and inflated to determine the available size of said intradiscal space.

Abstract: Open chambered spacers, implanting tools and methods are provided. The spacers 500? include a body 505? having a wall 506? which defines a chamber 530? and an opening 531? in communication with the chamber 530?. In one embodiment the wall 506? includes a pair of arms 520?, 521? facing one another and forming a mouth 525? to the chamber 530?. Preferably, one of the arms 520? is truncated relative to the other, forming a channel 526. In one aspect the body 505? is a bone dowel comprising an off-center plug from the diaphysis of a long bone. The tools 800 include spacer engaging means for engaging a spacer and occlusion means for blocking an opening defined in the spacer. In some embodiments, the occlusion means 820 includes a plate 821 extendable from the housing 805. In one specific embodiment the plate 821 defines a groove 822 which is disposed around a fastener 830 attached to the housing 805 so that the plate 821 is slideable relative to the housing 805.

Abstract: Open chambered spacers, implanting tools and methods are provided. The spacers 500? include a body 505? having a wall 506? which defines a chamber 530? and an opening 531? in communication with the chamber 530?. In one embodiment the wall 506? includes a pair of arms 520?, 521? facing one another and forming a mouth 525? to the chamber 530?. Preferably, one of the arms 520? is truncated relative to the other, forming a channel 526. In one aspect the body 505? is a bone dowel comprising an off-center plug from the diaphysis of a long bone. The tools 800 include spacer engaging means for engaging a spacer and occlusion means for blocking an opening defined in the spacer. In some embodiments, the occlusion means 820 includes a plate 821 extendable from the housing 805. In one specific embodiment the plate 821 defines a groove 822 which is disposed around a fastener 830 attached to the housing 805 so that the plate 821 is slideable relative to the housing 805.

Abstract: A system for dynamic stabilization of the spine includes a bone engaging fastener configured to be anchored in a vertebra and a deflectable element mounted on the fastener. The deflectable element or bumper is configured and arranged to contact a portion of an adjacent vertebra, such as the facet, during extension of the spine, while offering no resistance during flexion. In certain embodiments, a cable may be fastened to the bone engaging fastener and arranged to contact a portion of the adjacent vertebra, such as the spinous process, during flexion of the spine. In one surgical technique of the invention, a contralateral approach is used to introduce the bone engaging fastener through the deflectable element and into the vertebra.

Abstract: An expandable interbody fusion device for implantation into the intradiscal space between two opposing vertebral bodies of a spine comprises a superior endplate member having an upper surface for engaging a superior vertebral body in a spine, and an inferior endplate member having a lower surface for engaging an inferior vertebral body in the spine. The superior endplate member and the inferior endplate member are releasably coupled and define a cavity therebetween. At least one expansion member is configured to be introduced into the cavity to move the superior endplate and the inferior endplate members relatively apart upon introduction and to thereby decouple the superior endplate member and the inferior endplate member. An inserter may be releasably coupled to the device to facilitate insertion of the device as well as to provide a track for insertion of the expansion members.

Abstract: A vented needle is provided for use in sealably injecting biomaterial into an intradiscal space interiorly of the annulus of a spinal disc and for providing an exhaust for the intradiscal space. The vented needle comprises a compressible seal body for pressing against an outer surface of the annulus, and a needle extending through the seal. The needle may be configured to connect to a syringe for pressure injection of the biomaterial into the needle. The seal includes a vent extending therethrough the seal with an opening for communication with the intradiscal space and an opening for the discharge of excess biomaterial filling the intradiscal space. A kit of parts is also provided for use in the treatment of a spinal disc, the kit comprising the vented needle and an inflatable trial device.

Abstract: A method for treating a herniated spinal disc between opposing vertebral bodies having a damaged outer annulus and an inner nucleus pulposus comprises the steps of: providing access to the nucleus pulposus through the annulus; removing at least a portion of the nucleus pulposus to create an intradiscal space; applying a first distraction force on the opposing vertebral bodies from within the intradiscal space; applying a second distraction force on the opposing vertebral bodies externally of the intradiscal space; and introducing a curable biomaterial through the annulus access directly into the intradiscal space. The first distraction force is applied within the disc space to distract the anterior aspect of the intradiscal space, while the second distraction force is applied exterior to the disc to act on the posterior aspect of the vertebral bodies. The first distraction force is applied prior to the application of the second distraction force and then removed.

Abstract: A method for treating a diseased or damaged spinal disc comprises the steps of: (a) providing access to the nucleus pulposus through the annulus; (b) removing at least a portion of the nucleus pulposus to create an intradiscal space; determining the size of the intradiscal space; and (c) sealably introducing under pressure a curable biomaterial through the annulus directly into the intradiscal space. The method may include the additional steps of applying a force to distract the opposing vertebral bodies about the intradiscal space and then removing the distraction force after the biomaterial has cured. The step of determining the size of the intradiscal space may be accomplished by expanding a compliant balloon within the intradiscal space using a contrast medium capable of visualization under fluoroscopy. The curable material is sealably introduced through a vented needle inserted through the opening. The curable biomaterial is introduced until a quantity of the material flows into the vent.

Abstract: A method for treating a diseased or damaged spinal disc having an inner nucleus pulposus and an outer annulus is provided comprises the steps of: providing access to the nucleus pulposus through the annulus; removing at least a portion of the nucleus pulposus to create an intradiscal space; determining the integrity of the annulus; and then sealably introducing under pressure a curable biomaterial through the annulus access directly into the intradiscal space. The step of determining the integrity of the annulus may be accomplished by introducing into the disc a fluid solution under a first pressure. The curable biomaterial may subsequently be introduced through the annulus directly into said intradiscal space at a second pressure that is increased or decreased from the first pressure as a function of the viscosity of the biomaterial relative to the fluid solution. In certain embodiments, a distraction force is applied to the disc space.

Abstract: Open chambered spacers, implanting tools and methods are provided. The spacers 500? include a body 505? having a wall 506? which defines a chamber 530? and an opening 531? in communication with the chamber 530?. In one embodiment the wall 506? includes a pair of arms 520?, 521? facing one another and forming a mouth 525? to the chamber 530?. Preferably, one of the arms 520? is truncated relative to the other, forming a channel 526. In one aspect the body 505? is a bone dowel comprising an off-center plug from the diaphysis of a long bone. The tools 800 include spacer engaging means for engaging a spacer and occlusion means for blocking an opening defined in the spacer. In some embodiments, the occlusion means 820 includes a plate 821 extendable from the housing 805. In one specific embodiment the plate 821 defines a groove 822 which is disposed around a fastener 830 attached to the housing 805 so that the plate 821 is slideable relative to the housing 805.

Abstract: Implantable devices useful for creating bony fusion particularly in intervertebral spinal fusion. The device is formed of bone and has an at least partially demineralized portion between two rigid bone portions creating an area of flexibility. In one application, the area of flexibility may be used to move the device between a reduced size insertion configuration and an expanded implanted configuration. In another use, the area of flexibility may be useful to dampen shock applied to the implant. A method is also disclosed for making the implants and inserting the implants into an intervertebral disc space to promote interbody fusion.

Abstract: A dynamic stabilization system includes a stabilization element, such as a spinal rod, a plurality of bone anchors, such as bone bolts, and a like plurality of connectors for connecting the bolts to the spinal rod. At least some of the connectors include a flexible element between the bone anchor and the rod and an adjustment element for adjusting the flexibility of the flexible element, to thereby adjust the dynamic flexibility between the rod and the bone anchor. In one embodiment, the flexible element is a flexible bearing element of a rod end bearing.

Abstract: Spinal spacers 20 are provided for fusion of a motion segment. The spacers include a load bearing member 21 having a wall 22 sized for engagement within a space between adjacent vertebrae to maintain the space and an effective amount of an osteogenic composition to stimulate osteoinduction. The osteogenic composition includes a substantially pure osteogenic factor in a pharmaceutically acceptable carrier. In one embodiment the load bearing member includes a bone graft impregnated in an osteogenic composition. In another embodiment, the osteogenic composition 30 is packed within a chamber 25 defined in the graft. Any suitable configuration of a bone graft is contemplated, including bone dowels, D-shaped spacers and cortical rings.

Abstract: Open chambered spacers, implanting tools and methods are provided. The spacers 500′ include a body 505′ having a wall 506′ which defines a chamber 530′ and an opening 531′ in communication with the chamber 530′. In one embodiment the wall 506′ includes a pair of arms 520′, 521′ facing one another and forming a mouth 525′ to the chamber 530′. Preferably, one of the arms 520′ is truncated relative to the other, forming a channel 526. In one aspect the body 505′ is a bone dowel comprising an off-center plug from the diaphysis of a long bone. The tools 800 include spacer engaging means for engaging a spacer and occlusion means for blocking an opening defined in the spacer. In some embodiments, the occlusion means 820 includes a plate 821 extendable from the housing 805.

Abstract: Open chambered spacers, implanting tools and methods are provided. The spacers 500′ include a body 505′ having a wall 506′ which defines a chamber 530′ and an opening 531′ in communication with the chamber 530′. In one embodiment the wall 506′ includes a pair of arms 520′, 521′ facing one another and forming a mouth 525′ to the chamber 530′. Preferably, one of the arms 520′ is truncated relative to the other, forming a channel 526. In one aspect the body 505′ is a bone dowel comprising an off-center plug from the diaphysis of a long bone. The tools 800 include spacer engaging means for engaging a spacer and occlusion means for blocking an opening defined in the spacer. In some embodiments, the occlusion means 820 includes a plate 821 extendable from the housing 805.

Abstract: Open chambered spacers, implanting tools and methods are provided. The spacers 500′ include a body 505′ having a wall 506′ which defines a chamber 530′ and an opening 531′ in communication with the chamber 530′. In one embodiment the wall 506′ includes a pair of arms 520′, 521′ facing one another and forming a mouth 525′ to the chamber 530′. Preferably, one of the arms 520′ is truncated relative to the other, forming a channel 526. In one aspect the body 505′ is a bone dowel comprising an off-center plug from the diaphysis of a long bone. The tools 800 include spacer engaging means for engaging a spacer and occlusion means for blocking an opening defined in the spacer. In some embodiments, the occlusion means 820 includes a plate 821 extendable from the housing 805.

Abstract: Implantable devices useful for creating bony fusion particularly in intervetebral spinal fusion. The device is formed of bone and has an at least partially demineralized portion between two rigid bone portions creating an area of flexibility. In one application, the area of flexibility may be used to move the device between a reduced size insertion configuration and an expanded implanted configuration. In another use, the area of flexibility may be useful to dampen shock applied to the implant. A method is also disclosed for making the implants and inserting the implants into an intervertebral disc space to promote interbody fusion.

Abstract: Spinal spacers 20 are provided for fusion of a motion segment. The spacers include a load bearing member 21 having a wall 22 sized for engagement within a space between adjacent vertebrae to maintain the space and an effective amount of an osteogenic composition to stimulate osteoinduction. The osteogenic composition includes a substantially pure osteogenic factor in a pharmaceutically acceptable carrier. In one embodiment the load bearing member includes a bone graft impregnated in an osteogenic composition. In another embodiment, the osteogenic composition 30 is packed within a chamber 25 defined in the graft. Any suitable configuration of a bone graft is contemplated, including bone dowels, D-shaped spacers and cortical rings.